Rebecca L. Lester, and all others similarly situated; individually and as administrator of the Estate of Deceased Garry D. Lester v. Abiomed, Inc., et al.

CourtDistrict Court, N.D. Ohio
DecidedMarch 31, 2026
Docket1:25-cv-01081
StatusUnknown

This text of Rebecca L. Lester, and all others similarly situated; individually and as administrator of the Estate of Deceased Garry D. Lester v. Abiomed, Inc., et al. (Rebecca L. Lester, and all others similarly situated; individually and as administrator of the Estate of Deceased Garry D. Lester v. Abiomed, Inc., et al.) is published on Counsel Stack Legal Research, covering District Court, N.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Rebecca L. Lester, and all others similarly situated; individually and as administrator of the Estate of Deceased Garry D. Lester v. Abiomed, Inc., et al., (N.D. Ohio 2026).

Opinion

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION

Rebecca L. Lester, and all others similarly ) CASE NO. 1:25 CV 1081 situated; individually and as administrator ) of the Estate of Deceased Garry D. Lester, ) ) Plaintiffs, ) JUDGE PATRICIA A. GAUGHAN ) vs. ) ) Abiomed, Inc., et al., ) ) Memorandum of Opinion and Order ) Defendants. )

INTRODUCTION This matter is before the Court upon defendant Abiomed, Inc. and defendant Johnson & Johnson’s Partial Motion to Dismiss Plaintiff’s Amended Complaint and Motion to Strike Plaintiff’s Amended Class Allegations. This is a product liability case. For the reasons that follow, defendants’ Partial Motion to Dismiss Plaintiff’s Amended Complaint is GRANTED and defendants’ Motion to Strike Plaintiff’s Amended Class Allegations is GRANTED. BACKGROUND For purposes of ruling on the pending motion to dismiss, all well-plead factual allegations in plaintiff’s Amended Class Action Complaint (Doc. 20) are presumed true. Defendant Abiomed, Inc., which was acquired by defendant Johnson & Johnson in 2022 (together, “Defendants”1), manufactures assistive medical devices known as Impella blood pumps (the “Devices”). The Devices are Class III medical devices approved by the U.S. Food and Drug Administration (“FDA”) to assist the circulation of blood during coronary procedures. On December 5, 2016, the FDA granted premarket approval for the Devices, expanding the indications to include high-risk percutaneous coronary intervention (“PCI”) and cardiogenic shock. Soon after approval from the FDA for expanded use of the Devices for left ventricle high-risk PCI

procedures, healthcare providers sent Defendants Adverse Event Reports (“AERs”). As early as 2018, Defendants were aware that the Devices were perforating the ventricles of persons’ hearts and surrounding vessels and cardiovascular tissue. Despite knowledge of these AERs, Defendants concealed this information from the FDA and the public. Defendants allegedly concealed some 1,793 deaths and 6,573 serious injury AERs between December 2016 and September 2021. On or about May 27, 2021, Garry D. Lester (“Decedent”) had a Device placed into his left ventricle. Shortly after placement, Decedent became hypotensive. It was later determined that Decedent’s ventricle had been perforated, resulting in several, significant complications that led to Decedent’s serious injury and death on May 30, 2021.

In October 2021, Defendants issued a “Technical Bulletin” (“Bulletin”) to Abiomed Inc.’s sales force/representatives. The Bulletin made recommendations for avoiding left ventricle perforations with the Devices. Despite its issuance, the Bulletin was not universally known because

1 Although many of the events underlying this dispute occurred before Johnson & Johnson acquired Abiomed, Inc. in 2022, this Court generally attributes all actions to “Defendants” for purposes of resolving these motions. 2 Defendants did not alert the FDA of the revised guidance in the Bulletin, did not issue a recall, and did not update the instructions that were provided to customers when the Devices were sold. On March 1, 2023, the FDA visited Abiomed Inc.’s corporate offices to investigate complaints related to the Devices. The FDA’s investigation at Abiomed Inc.’s offices found certain Devices were adulterated, defectively manufactured and designed, nonconforming, and lacked sufficient warnings. The FDA then issued a Warning Letter on September 19, 2023. On December 27, 2023, Defendants initiated a recall for the Devices, specifically the Instructions for Use, which was posted on February

9, 2024, and the FDA reported to the public on March 21, 2024. On September 16, 2024, Plaintiff Rebecca Lester (“Plaintiff”) was informed by a competent licensed medical physician that a defective Device used in Decedent’s procedure most likely caused the left ventricle perforation that led to his death. Thereafter, Plaintiff filed suit against Defendants individually and as the administrator of the estate of Garry D. Lester, on behalf of herself, the estate, next of kin, and all others similarly situated. Plaintiff names the class as: All individuals and their respective estates/representatives who, until the date that notice is mailed to the Class, had a[ Device] inserted into their heart while under the care of a physician in the State of Ohio, and any other state in the United States, and who suffered a ventricular perforation and/or cardiovascular injuries, resulting in serious injury or death between January 1, 2018 and March 21, 2024.

(Doc. 20 ¶ 117.) ANALYSIS Through their instant motions, Defendants move to dismiss certain claims in Plaintiff’s Amended Complaint and strike all the class allegations. Plaintiff opposes both motions. The Court will address each in turn. 3 A. Defendants’ Partial Motion to Dismiss Defendants move to dismiss three of the ten claims raised in the Amended Complaint: Count V (Fraudulent Concealment), Count VI (Fraudulent Misrepresentation), and Count VII (Ohio’s Consumer Sales Practices Act (“OCSPA”)). Defendants contend that these three claims are abrogated by the Ohio Product Liability Act (“OPLA”).2 The OPLA, codified at Ohio Revised Code §§ 2307.71 to 2307.80, “explicitly eliminate[s] ‘all common law product liability claims or causes of action.’” Wimbush v. Wyeth, 619 F.3d 632, 639 (6th Cir. 2010) (quoting Ohio Rev. Code § 2307.71(B)); Evans v. Hanger Prosthetics &

Orthotics, Inc., 735 F. Supp. 2d 785, 795–96 (N.D. Ohio 2010) (“[W]hen the Ohio General Assembly enacted the current version of the OPLA, which became effective on April 7, 2005, it abrogated all common law claims relating to product liability causes of actions.” (citing Flex Homes, Inc. v. Ritz–Craft Corp. of Mich., Inc., 2009 WL 3242140, at *13 n.22 (N.D. Ohio Sept. 30, 2009))). Thus, in Ohio, all “product liability claims” must be brought pursuant to the OPLA. The OPLA defines a “product liability claim” as one “that seeks to recover compensatory damages from a manufacturer or supplier for death, physical injury to person, emotional distress, or physical damage to property other than the product in question” allegedly resulting from “the design, formulation, production, construction, creation, assembly, rebuilding, testing, or marketing

of that product,” “[a]ny warning or instruction, or lack of warning or instruction, associated with

2 By relying on cases applying Ohio law, the parties implicitly acknowledge that Ohio law governs this diversity action. See, e.g., Muncie Power Prod., Inc. v. United Techs. Auto., 328 F.3d 870, 873 (6th Cir. 2003) (summarizing that, where Ohio is the forum state, federal courts sitting in diversity apply a balancing test which presumes that “the law of the place where the injury occurs will be applied to a tort action” unless “another state has a more significant relationship to the action.”). 4 that product,” or “[a]ny failure of that product to conform to any relevant representation or warranty.” Ohio Rev. Code § 2307.71(A)(13). “Considering this statutory language, courts have routinely dismissed non-statutory product–liability claims brought under Ohio law.” McKinney v. Microsoft Corp., 2011 WL 13228141, at *7 (S.D. Ohio. May 12, 2011) (collecting cases).

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Amchem Products, Inc. v. Windsor
521 U.S. 591 (Supreme Court, 1997)
Wimbush Ex Rel. Estate of Buchanan v. Wyeth
619 F.3d 632 (Sixth Circuit, 2010)
Randleman v. Fidelity National Title Insurance
646 F.3d 347 (Sixth Circuit, 2011)
Wal-Mart Stores, Inc. v. Dukes
131 S. Ct. 2541 (Supreme Court, 2011)
Pilgrim v. Universal Health Card, LLC
660 F.3d 943 (Sixth Circuit, 2011)
In Re American Medical Systems, Inc. Pfizer, Inc.
75 F.3d 1069 (Sixth Circuit, 1996)
Evans v. Hanger Prosthetics & Orthotics, Inc.
735 F. Supp. 2d 785 (N.D. Ohio, 2010)
Temple v. Fleetwood Enterprises, Inc.
133 F. App'x 254 (Sixth Circuit, 2005)
Tyson Foods, Inc. v. Bouaphakeo
577 U.S. 442 (Supreme Court, 2016)
James Smith v. General Motors LLC
988 F.3d 873 (Sixth Circuit, 2021)
Young v. Nationwide Mutual Insurance
693 F.3d 532 (Sixth Circuit, 2012)
Reeves v. Pharmajet, Inc.
846 F. Supp. 2d 791 (N.D. Ohio, 2012)
Hogue v. Pfizer, Inc.
893 F. Supp. 2d 914 (S.D. Ohio, 2012)
Everhart v. Merrick Mfg. II, L.L.C.
2022 Ohio 4626 (Ohio Court of Appeals, 2022)
In re Nissan N. Am., Inc. Litig.
122 F.4th 239 (Sixth Circuit, 2024)
Dennis Speerly v. General Motors, LLC
143 F.4th 306 (Sixth Circuit, 2025)

Cite This Page — Counsel Stack

Bluebook (online)
Rebecca L. Lester, and all others similarly situated; individually and as administrator of the Estate of Deceased Garry D. Lester v. Abiomed, Inc., et al., Counsel Stack Legal Research, https://law.counselstack.com/opinion/rebecca-l-lester-and-all-others-similarly-situated-individually-and-as-ohnd-2026.